Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Vanderbilt University Medical Center
Summary
This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).
Description
One of the most common surgical procedures performed in older adults is total knee arthroplasty (TKA), with an estimated 1 million TKAs performed annually in the United States. TKA directly addresses the pathology underlying knee joint pain and mobility limitations resulting from osteoarthritis. For most patients, TKA is effective for pain reduction and increasing function. However, a subgroup of 15-20% of TKA patients report unsatisfactory long-term pain outcomes well after postsurgical healing has occurred despite technical success of the procedure. Chronic postsurgical pain (CPSP) following…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 50 or older * Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination) * Ability to read and write in English sufficiently to understand and complete study questionnaires * Undergoing unilateral primary TKA * Medical diagnosis of osteoarthritis * Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10. Exclusion Criteria: * Diagnosis of pre-existing neuropathy * Untreated hypo/hyperthyroidism * Untreated heart disease * Alanine transaminase/aspartate transaminase \>2x upper-lim…
Interventions
- DrugGlyNAC (combination of glycine and n-acetylcysteine)
GlyNAC 200 mg/kg/day (100mg glycine and 100mg N-acetyl-cysteine) will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively. The preparation will be a commercially available product of 1:1 ratio of glycine and N-acetyl-cysteine.
- DrugPlacebo
Placebo (alanine) 200 mg/kg/day will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.
Location
- Vanderbilt University Medical CenterNashville, Tennessee